(14 days)
The Microlife Digital Underarm Thermometer MT 18E1-1 (V932-1) is designed specifically for measuring underarm (axillary) temperatures.
Unlike regular thermometers, the unique elbow of the Digital Underarm thermometer is designed to find the " hotspot" easily and comfortably every time.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.
The provided document is a 510(k) Summary for a medical device cleared by the FDA, the Microlife Digital Underarm Electronic Thermometer, Model MT18E1-1 (V932-1). This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new acceptance criteria.
Based on the provided text, the device did not undergo a study to prove it meets acceptance criteria in the way a novel AI or diagnostic device might. Instead, its acceptance was based on showing substantial equivalence to a previously cleared predicate device.
Here's an analysis of the information requested, based on the document's content:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicitly stated acceptance criteria or performance metrics derived from a new clinical study are provided. The submission focuses on substantial equivalence to a predicate device and compliance with voluntary standards for thermometers. | Not applicable. The document does not report specific device performance metrics from a new clinical study against acceptance criteria. |
| Compliance with ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Device is compliant with ASTM E1112. |
| Compliance with IEC60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Device is compliant with IEC60601-1. |
| Compliance with IEC60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) | Device is compliant with IEC60601-1-2. |
| Compliance with ISO 10993 (Biological evaluation of medical devices) | Device is compliant with ISO 10993 (biocompatibility testing). |
| Substantial equivalence to predicate device (Micro Idea Instrument Digital Thermometer, Model MT3001/5001, K#851146) | Bench testing demonstrated that differences in characteristics do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document explicitly states "Discussion of Clinical Tests Performed: Not applicable." The acceptance was based on non-clinical tests (bench testing for standard compliance and comparison to predicate device). Therefore, there was no test set in the sense of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a digital thermometer, not an algorithm. Bench testing verified the device's performance against standards and the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" was established by voluntary standards (ASTM E1112, IEC60601-1, IEC60601-1-2, ISO 10993) and the performance characteristics of the predicate device. The fundamental principle of operation (thermistor resistance change correlated to temperature) is based on established physics, which serves as the underlying scientific ground truth for temperature measurement.
8. The sample size for the training set
- Not applicable. This device is a hardware product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.